Antibiotic Resistance Targeted in 21st Century Cures Act

WASHINGTON -- A provision in the 21st Century Cures Act recently passed by the House would require the CDC to make sure some of the bill's financial incentives aren't encouraging antibiotic resistance.

The amendment, sponsored by Rep. Louise Slaughter (D-N.Y.), a microbiologist, requires the CDC to issue a report within 3 years on a provision in the bill that mandates additional payments for so-called DISARM drugs for Medicare beneficiaries. DISARM (Developing an Innovative Strategy for Antimicrobial-Resistant Microorganisms) drugs are defined as those which meet an unmet medical need and that treat an infection associated with high rates of mortality or significant patient morbidity.

"Taxpayers shouldn't foot the bill for practices that make antibiotics less effective," Rep. Slaughter said in a statement. "We need new antibiotics now because we have frittered away the greatest medical advancement of my lifetime by overusing the ones we already had and hastening the development of resistance in bacteria. I am gravely concerned that paying hospitals more to use a new generation of antibiotics will just repeat the cycle of overuse and lead to ever more drug-resistant superbugs."

The 21st Century Cures Act -- which has yet to be considered by the Senate -- also requires that the Comptroller General conduct a study of any barriers that exist for development of DISARM drugs, and make recommendations on how to remove such barriers.

Amanda Jezek, vice president for public policy and government affairs at the Infectious Diseases Society of America, in Arlington, Va., said her organization is excited about the provision to report on financial incentives because "we are seeing more and more infections that can't be treated with [today's] antibiotics" due to increasing resistance.

She noted that the amendment was easily accepted by the bill's chief sponsor and chair of the Energy and Commerce Committee, Rep. Fred Upton (R-Mich.). "I think that speaks to the fact that there is a really strong [interest] in Congress to not only spur development of antibiotics but also to combat resistance with any tools at our disposal."

IDSA is also happy with another provision in the bill which would allow drugmakers to conduct smaller-than-usual clinical trials for the purpose of getting drugs approved for use in a subgroup of patients with serious or life-threatening infections. The provision -- adapted from a bill sponsored by Reps. Gene Green (D-Texas) and John Shimkus (R-Ill.) -- requires that the drug's sponsor still prove that the drug was safe and effective; it also requires that the drug be specially labeled and that its use be monitored to make sure it was not being prescribed inappropriately.

"This is something IDSA has been championing for a very long time," Jezek said. "If you look at superbugs, [they are] occurring in only a small number of patients, so it's really impossible to get enough patients to do a large clinical trial -- that's one reason these drugs are not being developed."

A staff member in Rep. Green's office said one reason for including the amendment is that "The pipeline for new antimicrobials is weak at best" In 1990, the staffer noted, there were 20 large research and development programs at pharmaceutical firms for the development of such drugs, but now there are only two or three such programs.

"We need a robust pipeline because we're already seeing [an estimated] 23,000 deaths in the U.S. from antibiotic-resistant infections, and that number is believed to underrepresent what's actually happening," the staff member said.

The idea of a "limited approval pathway" -- or "limited population pathway," as it is sometimes called -- using data from smaller clinical trials was actually floated originally by Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, the staffer said, because of the many restrictions involved in doing such clinical trials, including the requirement that patients can't enroll if they've previously taken another antibiotic unsuccessfully for the same condition.

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